Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift

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Exposure to loud sounds can cause hearing loss. The purpose of this research study is to evaluate potential prevention of temporary changes in hearing that may occur after listening to music through an iPod or personal music player. We will measure temporary changes in hearing in subjects who listen to music and take either the study drug, SPI-1005, or a placebo for 4 days. SPI-1005 is a proprietary preparation of ebselen that allows it to be taken by mouth. Ebselen contains the mineral selenium and behaves like Glutathione Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud sounds.

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Ages Eligible for Study:

18 Years to 31 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Healthy subjects at the time of enrollment.

Each subject will give informed consent to participate in this study and agrees to the treatment protocol.

Each subject will be interviewed regarding hearing and health to reveal any history of hearing loss, tinnitus, known ear pathology, use of any potentially ototoxic medications (i.e. diuretics, minocycline).

Non-occupational sound exposure (e.g., concerts, firearms, fireworks, power tools) will be avoided during the 24-hour period preceding baseline testing and throughout the duration of the study.

Exposure to any duration of non-occupational high-level sound (e.g., concerts, firearms, fireworks, power tools) during the 24 hour period preceding baseline audiometric testing as revealed in the subject questionnaire or during the medical examination.

Pathology of the external ear discovered upon otoscopic examination.

Pathology of the middle ear revealed by otoscopic examination, abnormal tympanometry, or reported history of middle ear problems.

Pathology of the inner ear or auditory nerve as revealed by reported history.

Subject complaints of aural pain, pressure, fullness, or drainage.

Subjects testing positive for pregnancy will be excluded from the study.

Subjects with other medical/health issues that would preclude voluntary participation in a drug study may be excluded at the discretion of the Principal Investigator.

Subjects that have previously received any known potentially ototoxic medication. This includes, but is not limited to, high dose salicylates (>2 g/day), platinum-based chemotherapeutics and aminoglycoside antibiotics, such as streptomycin, gentamicin,tobramycin, amikacin, neomycin, and netilmycin.

Subjects that are currently using of any potentially ototoxic medications (i.e. diuretics or minocycline).

Subjects that have received any investigational treatment (drug or device) in the six months prior to this study.